1. Field of the Invention
The present invention is directed to devices and methods that enable remote deflation of intragastric balloons used for the treatment of obesity, and in particular devices and methods that enable an implanted intragastric balloon to be remotely deflated while the device itself is in the stomach.
2. Description of the Related Art
Intragastric balloons are well known in the art as a means for treating obesity. One such inflatable intragastric balloon is described in U.S. Pat. No. 5,084,061 and is commercially available as the BioEnterics Intragastric Balloon System (sold under the trademark BIB®). These devices are designed to provide therapy for moderately obese individuals who need to shed pounds in preparation for surgery, or as part of a dietary or behavioral modification program.
The BIB System, for example, comprises a silicone elastomer intragastric balloon that is inserted into the stomach and filled with a fluid, for example, a saline solution or air. The intragastric balloon functions by filling the stomach and enhancing appetite control. Placement of the intragastric balloon is non-surgical, usually requiring no more than 20-30 minutes. The procedure is performed gastroscopically in an outpatient setting, typically using local anesthesia and sedation. Placement is temporary, and intragastric balloons are typically removed after six months.
Most intragastric balloons utilized for this purpose are placed in the stomach in an empty or deflated state and thereafter filled (fully or partially) with a suitable fluid. The balloon occupies space in the stomach, thereby leaving less room available for food and creating a feeling of satiety for the patient. Clinical results with these devices show that for many obese patients, the intragastric balloons significantly help to control appetite and accomplish weight loss.
Intragastric balloons typically are implanted for a finite period of time, usually lasting approximately six months. This time period may be shortened by a treating physician who wishes to alter the patient's treatment and remove the balloon prior to the six month period. In any event, at some point after the balloon has been surgically placed in the stomach, it will become desirable to remove the balloon from the stomach. One of the means of removing the balloon is to deflate it by puncturing the balloon, and either aspirating the contents of the balloon or allowing the fluid to pass into the patient's stomach. This means of removing saline from the balloon requires surgical intervention, through the use of a gastroscopic instrument. When the balloon is deflated in this manner, the balloon itself may be surgically removed using the gastroscopic instrument.
Alternatively, if the balloon is left in place beyond its designed lifetime, the acids present in a patient's stomach may erode the balloon to the point where it self-deflates. When this occurs, the deflated balloon may pass naturally through the patient's digestive system and be expelled through the bowel.
Those experienced in the art will readily appreciate that manipulating the balloon in situ in order to deflate the balloon can be difficult. This is because the balloon is slippery and positionally unstable. The usually spherical or ellipsoidal intragastric balloons may readily rotate in the stomach, making it difficult for a surgeon to manipulate the balloon in order to find a deflation valve, or to safely puncture the balloon using a surgical instrument.
It may become desirable, then, particularly when the balloon is to be removed from the body, to cause the deflation of the balloon remotely without surgical intervention.
Therefore, the present invention is directed at overcoming the problems associated with the prior art systems. These and other objects of the present invention will become apparent from the further disclosure to be made in the detailed descriptions given below.